FDA.reportPublic FDA data

Roflumilast

Product NDC
31722-623
Requested package NDC
31722-623-30
11-digit product format
317220623
Labeler code
31722
Product ID
31722-623_fa61de4b-e3e1-e16c-e053-6394a90a6118
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Roflumilast
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA208213
Marketing category
ANDA
Marketing start
2022-10-15
Substance
ROFLUMILAST
Active strength
500 ug/1
Pharmacologic classes
Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208213-001ROFLUMILASTROFLUMILAST500MCGTABLET / ORALAB2018-11-23
A208213-002ROFLUMILASTROFLUMILAST250MCGTABLET / ORALAB2023-04-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A208213-001AB
A208213-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A208213-001ROFLUMILAST500MCGTABLET / ORALAB2018-11-23a50c72e98297…
2026-08-01 22:54:322026-06A208213-002ROFLUMILAST250MCGTABLET / ORALAB2023-04-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208213-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208213-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RoflumilastROFLUMILASTAmerican Health Packaging913f1b95-9c46-40d5-a6e9-cff2e5e07eaa2024-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208213
application number: ANDA208213
RoflumilastROFLUMILASTCamber Pharmaceuticals, Inc.f25a0230-3cf6-4366-bebe-0ea5ff8de5ab2023-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208213
application number: ANDA208213
ndc (package): 31722-623-30
ndc (product): 31722-623
ndc11 (package): 31722062330

Additional Listing Data#

Finished product
Yes
Brand name base
Roflumilast
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROFLUMILAST500 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0P6C6ZOP5UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1091839Internal RxNorm lookup
2001319Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f25a0230-3cf6-4366-bebe-0ea5ff8de5abAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dcb8b904-8d4f-458b-b954-4eae028a2651Product name220250305
a1a743b6-f2e2-4044-a176-5c60c71ece24Product name120250102
6ac6be18-9820-1c07-b72b-a35dcf9d14c7Product name920240501

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-623-30Roflumilast30 in 1 BOTTLETABLET302
31722-623-31Roflumilast10 in 1 BLISTER PACKTABLET102
31722-623-32Roflumilast100 in 1 CARTONTABLET1002
31722-623-90Roflumilast90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-623-30EA - Each31722-62370363118-541c-4f96-a313-2f3d413478db12022-11-07
31722-623-90EA - Each31722-6233b2c8a7a-91f0-4cbd-a794-508b855864d412022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-623ROFLUMILAST (ROFLUMILAST) TABLET [CAMBER PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 4 package rows20230429_f25a0230-3cf6-4366-bebe-0ea5ff8de5ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001319roflumilast 250 MCG Oral TabletPSNf25a0230-3cf6-4366-bebe-0ea5ff8de5ab2
1091839roflumilast 500 MCG Oral TabletPSN913f1b95-9c46-40d5-a6e9-cff2e5e07eaa2
1091839roflumilast 500 MCG Oral TabletPSNf25a0230-3cf6-4366-bebe-0ea5ff8de5ab2
2001319roflumilast 0.25 MG Oral TabletSCDf25a0230-3cf6-4366-bebe-0ea5ff8de5ab2
1091839roflumilast 0.5 MG Oral TabletSCD913f1b95-9c46-40d5-a6e9-cff2e5e07eaa2
1091839roflumilast 0.5 MG Oral TabletSCDf25a0230-3cf6-4366-bebe-0ea5ff8de5ab2
2001319roflumilast 250 MCG Oral TabletSYf25a0230-3cf6-4366-bebe-0ea5ff8de5ab2
1091839roflumilast 500 MCG Oral TabletSY913f1b95-9c46-40d5-a6e9-cff2e5e07eaa2
1091839roflumilast 500 MCG Oral TabletSYf25a0230-3cf6-4366-bebe-0ea5ff8de5ab2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-623-303172206233030 TABLET in 1 BOTTLE (31722-623-30) 30 tablet2022-10-150000-00-00NoNoCurrent